Emricasan, a Caspase Inhibitor, for Treatment of Subjects With Decompensated NASH Cirrhosis
NCT ID: NCT03205345
Last Updated: 2019-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
210 participants
INTERVENTIONAL
2017-06-28
2019-08-31
Brief Summary
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Detailed Description
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For each subject, the study will consist of:
* Screening period of up to 4 weeks
* Randomized, double-blind treatment period of at least 48 weeks
* A follow-up visit 2 weeks after completion of study drug treatment
The duration of each subject's participation will be at least 54 weeks for those completing the entire study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Emricasan (25 mg)
Emricasan 25 mg
Emricasan (25 mg)
25 mg emricasan
Emricasan (5 mg)
Emricasan 5mg
Emricasan (5 mg)
5 mg emricasan
Placebo
Matching placebo
Placebo
Matching Placebo
Interventions
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Emricasan (25 mg)
25 mg emricasan
Emricasan (5 mg)
5 mg emricasan
Placebo
Matching Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Cirrhosis due to NASH with exclusion of other causes of cirrhosis (e.g. chronic viral hepatitis, alcoholic liver disease, etc.)
3. At least one of the following: a) history of variceal hemorrhage (more than 3 months prior to day 1) documented on endoscopy and requiring blood transfusion, b) history of at least moderate ascites (on physical exam or imaging) currently treated with diuretics.
4. MELD score ≥12 and ≤20 during screening
5. Albumin ≥2.5 g/dL during screening
6. Serum creatinine ≤1.5 mg/dL during screening
Exclusion Criteria
2. Non-cirrhotic portal hypertension
3. Child-Pugh score ≥10
4. Current use of anticoagulants that affect prothrombin time or international normalized ratio
5. ALT \>3 times upper limit of normal (ULN) or AST \>5 times ULN during screening
6. Initiation or discontinuation of non-selective beta blockers within 1 month of screening
7. Transjugular intrahepatic portosystemic shunt or other porto-systemic bypass procedure within 1 year of screening or previously requiring revision
8. Alpha-fetoprotein \>50 ng/mL in the last year
9. History of hepatocellular carcinoma (HCC) or evidence of HCC
10. History of malignancies other than HCC, unless successfully treated with curative intent and believed to be cured
11. Prior liver transplant
12. Uncontrolled diabetes mellitus (HbA1c \>9%)
13. Change in diabetes medications or vitamin E within 3 months of screening
14. Restrictive bariatric surgery or bariatric device within 1 year of screening or prior malabsorptive bariatric surgery
15. Symptoms of biliary colic unless resolved following cholecystectomy
16. History of significant alcohol consumption within the past 5 years
17. Current use of medications that are considered inhibitors of organic anion transporting polypeptide OATP1B1 and OATP1B3 transporters
18. Prolongation of screening (pre-treatment) QTcF interval of \>500 msecs, or history or presence of clinically concerning cardiac arrhythmias
19. Significant systemic or major illness other than liver disease
20. Human immunodeficiency virus infection
21. Use of alcohol, controlled substances (including inhaled or injected drugs), or non-prescribed use of prescription drugs within 1 year of screening to the point of interfering with the subject's ability to comply with study procedures and study drug administration in the investigator's judgement
18 Years
ALL
No
Sponsors
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Conatus Pharmaceuticals Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jean L Chan, MD
Role: STUDY_DIRECTOR
Conatus Pharmaceuticals Inc.
Locations
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The Institute for Liver Health
Chandler, Arizona, United States
St. Joseph's Hospital & Medical Center
Phoenix, Arizona, United States
Mayo Clinic Arizona
Phoenix, Arizona, United States
University of Arizona Liver Research Institute
Tucson, Arizona, United States
University of California, San Francisco-Fresno
Fresno, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
UCLA Pfleger Liver Institute
Los Angeles, California, United States
California Liver Research Institute
Pasadena, California, United States
Stanford University
Redwood City, California, United States
Inland Empire Liver Foundation
Rialto, California, United States
UC Davis GI/Hepatology Clinical Trials Unit
Sacramento, California, United States
Scripps Clinic - Torrey Pines
San Diego, California, United States
California Pacific Medical Center
San Francisco, California, United States
University of California San Francisco
San Francisco, California, United States
University of Colorado Denver
Aurora, Colorado, United States
Peak Enterology Associates
Colorado Springs, Colorado, United States
West Haven VA Medical Center
West Haven, Connecticut, United States
UF Hepatology Research at CTRB
Gainesville, Florida, United States
Mayo Clinic
Jacksonville, Florida, United States
Florida Research Institute
Lakewood Rch, Florida, United States
Schiff Center for Liver Disease/University of Miami
Miami, Florida, United States
Florida Hospital Transplant Institute
Orlando, Florida, United States
IMIC Inc.
Palmetto Bay, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Piedmont Transplant Institute
Atlanta, Georgia, United States
Gastrointestinal Specialists of Georgia
Marietta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
Aquiant Research
Albany, Indiana, United States
Indiana University
Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics/ Internal Medicine
Iowa City, Iowa, United States
Delta Research Partners
Bastrop, Louisiana, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Mercy Medical Center
Baltimore, Maryland, United States
Walter Reed National Military Medical Center (WRNMMC)
Bethesda, Maryland, United States
Digestive Disease Associates, PA
Catonsville, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
University of Mississippi Medical Center, Division of Digestive Diseases
Jackson, Mississippi, United States
Kansas City Research Institute
Kansas City, Missouri, United States
Rutgers New Jersey Medical School
Newark, New Jersey, United States
Northwell Health Inc., Sandra Atlas Bass Center for Liver Diseases.
Manhasset, New York, United States
NYU Medical Center
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
Columbia University Medical Center - Center for Liver Disease and Transplantation
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Carolinas Healthcare System, Center for Liver Disease
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Diabetes & Endocrinology Consultants, PC
Morehead City, North Carolina, United States
UC Health/ UCPC LLC
Cincinnati, Ohio, United States
Options Health Research, LLC
Tulsa, Oklahoma, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
GHS Gastroenterology and Liver Center
Greenville, South Carolina, United States
ClinSearch, LLC
Chattanooga, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Texas Clinical Research Institute
Arlington, Texas, United States
Methodist Health System Clinical Research Institute
Dallas, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Baylor Scott & White Research Institute
Fort Worth, Texas, United States
Baylor College of Medicine - Advanced Liver Therapies
Houston, Texas, United States
Liver Associates of Texas, P.A.
Houston, Texas, United States
American Research Corporation at the Texas Liver Institue
San Antonio, Texas, United States
Methodist Specialty & Transplant Hospital
San Antonio, Texas, United States
San Antonio Military Medical Center
San Antonio, Texas, United States
University of Utah
Salt Lake City, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
Emeritas Research Group LLC
Leesburg, Virginia, United States
Banner University Medical Center - Phoenix Transplant Institute
Newport News, Virginia, United States
Bon Secours Liver Institute of Virginia
Richmond, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Swedish Organ Transplant and Liver Center
Seattle, Washington, United States
University of Washington Harborview Medical Center
Seattle, Washington, United States
University of Washington
Seattle, Washington, United States
Countries
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References
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Frenette C, Kayali Z, Mena E, Mantry PS, Lucas KJ, Neff G, Rodriguez M, Thuluvath PJ, Weinberg E, Bhandari BR, Robinson J, Wedick N, Chan JL, Hagerty DT, Kowdley KV; IDN-6556-17 Study Investigators. Emricasan to prevent new decompensation in patients with NASH-related decompensated cirrhosis. J Hepatol. 2021 Feb;74(2):274-282. doi: 10.1016/j.jhep.2020.09.029. Epub 2020 Oct 8.
Other Identifiers
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IDN-6556-17
Identifier Type: -
Identifier Source: org_study_id
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